Mayo Clinic cardiologist Christopher V. DeSimone, M.D., Ph.D., speaks with Sorin V. Pislaru, M.D., Ph.D., on how thrombosis contributes to valve failures and reoperations and what can be done to avoid it in this video first shown on Medscape Cardiology .
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mhm mm hmm. Hello and welcome back to the male clinic Medscape video series. I'm dr Christopher DeSimone, cardiologist and director of marketing. And today we'll be discussing bio prosthetic valve thrombosis. I'm joined by my colleague dr Soran piss Larue consultant and professor of medicine and an expert in this area. Welcome dr Pistolero. Thanks for having me chris it's a great pleasure to to talk about by prosthetic thrombosis. I know this is an area of passion for you and you're an expert. So we just want to start off by asking what is bio prosthetic valve thrombosis And when do you find it occurring? So this is a long story. You know the Carpentier implanted the first Xena graft in a patient in the sixties. And you can imagine at that time neither econ or city were available for routine evaluation. So it took a little while for the cases of bio prosthetic thrombosis to trickle into the literature And for a long, long time the disease was considered to be a rare event. Their skates reports of one or at most two patients or so who had by president from moses through the 70s and 80s. And then people start to realize that this may be actually more common than than what you think. We have a group here of several cardiologists and cardiac surgeons who became interested in the phenomenon early on and we started looking deeper into into our reports. So so what is it? Well it's simple, it's strong emphasis of a bio prosthesis. They are supposed to not have that event. We do anti coagulate routinely after implantation. So it was felt that once you're past those three months in which the valve Rionda, she realizes you're out of the woods. And what we've seen actually is that you do have true moses that occurs late after implantation, meaning in year two, year three, year four post implantation. And the latest we've seen was a little over 10 years after after the initial event. But the bulk of them occurred somewhere between years one and three. So that would be the big. Perfect. And I know it's very difficult depending on the study that you the population that you study but in your population, what's the incidence of bio prosthesis? This seems like a very serious topic and could have lots of ramifications for our patients. So what's the incidents by a prosthetic thrombosis? So chris just just as you pointed out, I think, I think you're largely depending on at which population you look at and what's the methodology of looking at. So if you look retrospectively like we started doing in early 2011, what we noticed is that the incidents was not very high. So one of the first papers published from our group looked at patients who needed a re operation for a bio prosthetic valve and in that series the Uh presence of Trump's on by prosthetic valve as a reason for the valve failure was president, about 10% of the patient Of course that's not the total number of patients. And if you say during that study interval how many bio prosthetic valves have been implanted at the Mayo clinic? And you say as a percentage of that total number of incidents would be about 1%. So that's all retrospective. Now raj. My car had a huge impact on on the literature with his paper in New England in 2000 and 15 where they looked systematically with four D. C. T. At patients who had transported aortic valve replacement. And once you go to that study you see that the incident becomes much higher. So they quoted around 10 to 12% incidents at one month. And there are several registries from various groups that that show an incidence of about 10 to 12 to 15% by prostate valve thrombosis at one month post implantation in translated aortic valve. So what's the difference between the two? Well I guess we never look with cities in a systematic fashion in our population. So could we have missed some patients? Yes at the same time remember that all cover valves in all the clinical trials did not require anti coagulation. So patients were placed on dual anti platelet therapy. So was that the problem is that the reason why they have more thrombosis? Very hard to tell my guess. It's probably somewhere in between between 1% and 10%. Somewhere there? Excellent. So that was one of my questions was you know given now that we're doing lots of trans catheter valves. Is there something inherently different about the valve or is it just the anti thrombin attic anti coagulant regimen? It's a good question. And and uh, fortunately we now have an answer. So for a long time people said that translated a valve and surgical valves are different meaning that hey, there's a neo sinus because you have now the valve stand that's implanted there, you have the native valve that remains in place. Whereas the surgical valve will require the removal of the aortic valve. Native aortic valve. So there was a lot of discussion why the incidence is so low in surgical valves and so high and translated valve. And I always felt that they shouldn't be all that different. And I always thought that, well, maybe we don't find them in surgical. That's because we don't look. And uh just last year, in an uh spring, both the partner group and the core valve group published their results in the randomized trial for low risk patients. And they both showed that patients in surgical group and in translator group had significant incidents of, by prosthetic thrombosis. That was quite a bit, it was actually In the order of 10-20% for surgical valves to um, so not that different from transplanted valves at one year term when the incidents was 20-30%. So I think I think they are just the same valves is just you start looking, you'll start finding very interesting. So now I guess the next question to me would be you have an episode of this valve thrombosis and you treated however you want to treat it with anti coagulation, you re image the patient they do fine long term. Tell us is there anything that these patients are at higher risk of? Are we more worried about these patients? Should we be imaging more seriously with them in parallel? What do you think? What are your thoughts? I think I think this this again, it's a field in motion and our most recent study looked exactly at this question, What happens with those patients who were identified as having a clinical episode of by prostate thrombosis, meaning that a clinician has recognized the event, has treated a patient with anti coagulation. And then what happens with that patient follow up after anti coagulation resolved the initial problem. And it turns out that in terms of strokes, um and peripheral anabolic events. These patients do not do any different than patients who never had by prostate valve thrombosis globally. Now, these are small numbers. So if you go large numbers, you may be able to pinpoint differences in these. But what we've seen are two important things. One in four patients who had one episode of ALF thrombosis will have a second and sometimes third or fourth episode of al thrombosis. So in other words, once you stop treating them with anti coagulation because you said, hey, we fixed your valve, you're home free. You need to be very, very careful. And my personal feeling is that if the patient who had a valve thrombosis is at very low risk for bleeding, it would not be unreasonable to consider long term anti calculation for these patients. So that's problem number 11 in four will have another episode of altering bodies. Uh The second problem is, do you restore prestigious longevity? So you diagnose the disease you treat effectively with anti coagulation? Are you going to restore the lifespan of the valve? And the answer that is probably not. So what we did, we took patients who had successfully treated by prostate thrombosis uh and match them to patients who had the same type of valve, same size and gender. Same year of implantation and so and so forth. And then if you go at long term, follow out what we saw at 10 years was that really patients who did have valve thrombosis are more likely to need another intervention on the valve. Be that a new valve in valve for a surgical intervention. So chance of that was close to 70% at 10 years versus about 2025% in control. So, so we think that by proceed thrombosis. Hastings prosthetic degeneration, which you could imagine. Uh well it's related to the traumatic event in the first place, I hope that once we see long term data from randomized trials from part and core valve. Uh those patients who were found to have evolved from bosses by for the city will be followed up obviously as part of the clinical trial. And we will see what happens at three years, five years, 10 years time in terms of randomized clinical trial. That will be very interesting to see. Very good. So it's really nice to have an expert like you giving us a glimpse into the future. If I had to just pin you down for our viewers and say right now, if you had a patient that came in with his prosthetic valve thrombosis, which anticoagulant plus or minus anti platelet, would you choose? And for how long do you need to treat them? I know you alluded to as long as we can as being safe. But what would you say is guidelines for our practitioners? So in general every patient has a buy prosthetic valve or a mechanical valve for that matter. We recommend that they are on aspirin. The guidelines in 2020 and 2017, 2008. All the recent editions of the valuable guidelines support the use of aspirin, every type of prosthesis. So, so aspirin is go many times aspirin has been replaced by Plavix. In these patients who have concomitant current disease and extends and so on and so forth. So that's a month. Now when you diagnose the trump is on the valve, then the question is, do you go to Warfarin or do you go with novel anticoagulants? Because all our experience or most of our experience has been with the warfarin anti coagulation. We tend to go to Warfarin anti coagulation. As you know, the current guidelines allow use of novel anticoagulants for uh non valvular indications such as later fibrillation and such uh in patients who have by prosthetic valves. But there is no long term evidence for that. I was obviously very disappointed when the when the Galileo trial was stopped prematurely because of excess bleeding and excess death in patients treated with River Rock Saban in by prosthetic Trumbo's in by prosthetic valves after tavern. So, so that was not a good signal. Now, is this across the class or? Yes or no. Hard to tell. We did use novel or atlantic wagons in a small number of patients and several groups have used successful do ax with my prostate from bosses. But I would say right this minute, there is more evidence with warfarin that with dough ax in terms of treating by prostate valve thrombosis. And then the question is for how long? First of all, I would advise everybody who deals with a patient who has by Preston evolved from poses be patient. Um We haven't published this yet, but it's currently under review and hopefully will come out eventually we looked at how long does it take for the gradient to normalize? If you put somebody on on anti coagulation and it turns out that you need to wait for a little while uh the mitral valve prosthesis respond relatively fast. So if you look at patients who have might revolve by Project Trumbo's is probably within 3-6 months. Almost 100% of them will resolve. But if you look at the aortic prosthesis and trikus pick prosthesis, it will take 69, 12 months, sometimes up to 18 months to resolve an event of bipoc thrombosis meaning that the morphological abnormalities on the valve by city or by echo have disappeared and that the gradient has returned to normal. So it takes quite a quite a while to to obtain your full restoration of valve function in new york and track aspect position. So be patient. Excellent. Well thank you Doctor Sparrow for these very important insights and thank you for joining us on the heart dot org. Medscape cardiology. It's a pleasure participating. Thank you for the invitation chris
